1. Wallach JD, Ross JS, Naci H. The US Food and Drug Administration’s expedited approval programs: addressing premarket flexibility with enhanced postmarket evidence generation. Clin Trials. 2018;15(3):243–6.
2. Psaty BM, Meslin EM, Breckenridge A. A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report. JAMA. 2012;307(23):2491–2.
3. U.S. Food and Drug Administration (FDA). Guidance for Industry: Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act. April 2011.
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf
. Accessed 10 Nov 2017.
4. U.S. Food and Drug Administration (FDA). Postmarketing Requirements and Commitments: Introduction.
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm
. Updated January 12, 2016. Accessed 10 Mar 2017.
5. Department of Health and Human Services Office of Inspector General. June 2006. FDA’s Monitoring of Postmarketing Study Commitments.
https://oig.hhs.gov/oei/reports/oei-01-04-00390.pdf
. Accessed 10 Sept 2018.